Medical devices which are usually provided in a sterile condition prior to use, are commonly protected during storage and handling by some form of packaging. This package typically includes one or more of the following desirable characteristics to maintain the sterility of the device prior to use. First, the packaging should effectively maintain the sterility of those elements of the device which will contact the patient, or which will be in contact with fluids to be administered to the patient. Second, the package should be "tamper-evident" or "use-evident" so that the user will be able to readily determine whether or not the sterility of the device may have been compromised prior to use. Third, the packaging should not impede the user's access to the device by requiring the disposal or removal of various components of the packaging prior to use. Fourth, the packaging should not require a modification of the conventional technique for Using the device. Fifth, the costs of manufacturing, shipping, storage and disposal of the device should be minimized by reducing the number and complexity of the components required for the packaged device. Finally, the packaging should provide adequate mechanical protection to ensure that the sterility of the device is maintained during shipping or storage.
In the prior art, one common method of packaging medical devices, such as syringes, has been to enclose the entire device in a sterile plastic or paper-type of package. U.S. Pat. No. 3,008,570 granted to Roehr et al. and U.S. Pat. No. 3,381,813 granted to Coanda et al. disclose packages wherein the entire syringe and needle or needle alone are fully enclosed within a plastic package. As disclosed in the Roehr et al. patent, the package preferably includes one or more frangible seals thereon to provide the user with an indication of when the package has been previously opened.
Another common approach to packaging syringes is to use the outer surface of the syringe barrel as part of the packaging. An early form of this approach is illustrated in U.S. Pat. No. 3,485,239 granted to Vanderbeck wherein an adhesive gas permeable wrap is positioned along the distal and proximal portions of the syringe assembly. A variation on this approach is disclosed in U.S. Pat. No. 4,300,678 granted to Gyure et al. wherein a cap member seals the proximal end of the syringe assembly and a frangible member, or a peelable section of material is used to seal the distal portion of the syringe assembly. Similarly, U.S. Pat. No. 3,828,775 granted to Armel discloses a device wherein a proximal cap encloses the proximal end of the syringe assembly and a frangible member encloses the distal end of the syringe barrel. A further variation on this approach is disclosed in U.S. Pat. No. 4,929,232 granted to Sweeney et al. wherein a cap member seals the proximal end of the syringe assembly and a securement collar is used to retain the needle shield on the distal end of the syringe barrel.
The packaging used in the above-described devices is believed to provide effective protection for the sterility of the syringes but they all fail to meet one or more of the desirable characteristics described above. One common deficiency of the above-described packaging occurs through the use of a cap or other member on the proximal end of the syringe assembly which must be discarded each time the syringe assembly is used. This is commonly considered to be nuisance trash because it is small and is usually left lying around the nurses station or other area where the device is opened. Similar complaints are found with packaging which includes a tearable or peelable seal to protect either the distal or proximal end of the syringe due to the need to discard the seal prior to Use of the syringe assembly.
Therefore, a need remains in the art for a package or device which satisfies all of the desirable characteristics described above without producing nuisance trash. As set forth more fully below, the present invention eliminates the need for a proximal end cap on the proximal end of the syringe barrel while providing an effective barrier which maintains the sterility of the interior surface of the syringe barrel prior to use. The barrier on the distal end of the present invention maintains the sterility of the distal portion of the syringe assembly and may take many forms as described more fully below depending on whether or not the device is packaged with a preattached needle.